NCT03068936

Brief Summary

Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower. Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
716

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 3, 2017

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

February 15, 2017

Last Update Submit

February 27, 2017

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal CarcinomaIntensity modulated radiotherapyCisplatin

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    Refers to the time from included to death due to any cause.

    up to 3 years

Study Arms (2)

IMRT group

EXPERIMENTAL

Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)

Radiation: Intensity modulated radiotherapy

IMRT plus cisplatin group

OTHER

Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times

Radiation: Intensity modulated radiotherapyDrug: Cisplatin

Interventions

Intensity modulated radiotherapyRADIATION

Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)

Also known as: IMRT
IMRT groupIMRT plus cisplatin group
CisplatinDRUG

Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times

IMRT plus cisplatin group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The sex of the subject is not limited, the age is from 18 to 70 years old;
  • Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
  • Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
  • Karnofsky score ≥ 80 points;
  • No evidence of distant metastasis;
  • Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.

You may not qualify if:

  • The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
  • Previously received immunotherapy;
  • Previously received chemotherapy;
  • Previously received radiation therapy;
  • Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
  • Evidence of distant metastases or other malignancies at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-ModulatedCisplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Dehua Wu

CONTACT

1860206274818602062748@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2017

First Posted

March 3, 2017

Study Start

March 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2021

Last Updated

March 3, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share